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Value-based
pharmaceutical contracts, sometimes referred to as risk sharing
agreements between pharmaceutical manufacturers and health plans or
other purchasers are critical in today’s very complex and costly
healthcare marketplace. These agreements allow placement of high-risk,
high-cost and often times specialty pharmaceutical products onto
purchaser formularies through basing payment on outcomes as opposed to
volume metrics. The concept has become popular in single payor systems,
and is beginning to take flight in the U.S. as evidenced by several high
profile value based contracts between pharmaceutical manufacturers and
health plans. However, as with every new concept in the U.S. health care
arena, there are growing pains, fear and uncertainty.

Tactics and techniques in developing and
executing successful value based pharmaceutical contracts start with
assessing value and defining risk from both the pharmaceutical
manufacturer and purchaser perspectives, and specifying the role of
applicable third party data assessors in value determinations. Contract
terms must be negotiated within the risk definition and risk tolerance
of both parties. The targeted outcomes, and the processes in determining
and documenting them, need to be fully examined, including: the
consequences of failing to meet the outcome and any payment increase for
proven value; the development of criteria for demonstrating
outcomes and value of product; the timeframes involved and
responsibility for evaluation of results; and determination of the
parties to be responsible for data collection and and the
procedures involved.

In order to establish a value-based contract, pharmaceutical
manufacturers as well as purchasers must understand the complexity of
these agreements and the legal implications associated with it.
Manufacturers will need to ensure safe harbor protection under the
Anti-Kickback Statute to enter qualified value based contracts. As there
is a greater exchange of more data between stakeholders, manufacturers
must mitigate HIPAA risks including reporting of adverse events and
sharing of patient data. They must also understand the legal regulations
necessary to take into account within value based contracts.

Special concerns must be addressed in pharmaceutical value based
agreements with non-traditional purchasers such as hospitals, hospital
systems, integrated delivery networks (IDNs) and ACOs. These challenges
include rebates and government programs, and incorporating provisions in
regard to these agreements to compliantly address
best price calculations.

Please join us Thursday, September 14, 2017 at 1
PM Eastern as Sidley Austin's William A. Sarraille
discusses trends; alternative structures; legal and compliance issues;
network features, benefits and disadvantages; and current examples
around the country in the HealthcareWebSummit event: Value Based Rx
Contracting Tactics and Techniques: Navigating Legal and Regulatory
Complexities.

After attending this webinar, attendees will be
able to:

Explore various tactics and techniques
to be applied in developing and executing successful value based
pharmaceutical contracts.

Examine considerations in
determination and documentation of targeted outcomes, and the
processes involved.

Understand the anti-kickback statute and discount safe harbors
as they apply to value based contracts

Evaluate HIPAA risks related to the collection and sharing of
patient level data and reporting of adverse events

Discuss the basis for government price reporting and how it
affects contract considerations.

Engage in interactive learning through online question
submission, attendee feedback and opportunity for follow up
questions, and networking with attendees, faculty and other
professionals through dedicated LinkedIn group.

Interested attendees would include:

C-Suite Executives

Legal, Regulatory and
Compliance Executives and Staff

Contracting Executives and Staff

Value and Outcomes Based Payment Executives and Staff

Pharmaceutical benefit Executives and Staff

Managed Market
Executives and Staff

Planning and Strategic
Executives and Staff

Business Intelligence
Staff

Other Interested
Partie

s

Attendees would represent
organizations including:

Life Science Organizations

Health Plans

PBMs

Third Party Adminsitrators

Employers

Hospitals and Health Systems

Accountable Care Organizations

Provider Networks

Government

Consulting Organizations

Solutions Providers

Associations, Institutes and Research Organizations

Media

Other Interested Organizations

Individual Registration Fee:
$195.
Post-event materials, with video syncing slides and recorded
audio, plus presentation pdf file: $45
for attendees; $260 for non-attendees after the event.
Register online or
download the event brochure. Attendees will
also receive a free subscription to the semi-monthly Managed
Markets e-newsletter.

Bill Sarraille is a senior member of the Healthcare practice
group and a nationally-recognized lawyer in healthcare law.
Bill concentrates on a variety of healthcare matters,
including Medicare and Medicaid reimbursement, coverage and
coding, pharmaceutical price reporting, issues related to
the marketing and promotion of pharmaceuticals and medical
devices, internal investigations, clinical research issues,
Stark and Anti-Kickback Law analyses, Medicare and Medicaid
audits, healthcare acquisitions and due diligence,
compliance program audits, managed care matters, healthcare
contracts, administrative litigation, legislative matters,
privacy and security, coverage for new devices and services,
the Foreign Corrupt Practices Act, international compliance
and healthcare contracting, the representation of witnesses
and companies before Congressional Committees, and the
defense of healthcare criminal and False Claims Act matters.
Bill has defended clients in some of the largest healthcare
fraud investigations brought by the U.S. Government.

Bill is consistently recognized as a leading healthcare
lawyer in Chambers USA and LMG Life Sciences. He was named
an LMG Life Sciences star in 2013, 2014 and 2015, and has
been recognized every year since 2013 in Chambers USA as a
leading lawyer both in D.C. and nationwide. Chambers notes
that sources describe Bill as a "terrific regulatory
healthcare lawyer" with a "wide range of experience” and
noted he is “an excellent reimbursement lawyer.” The
directory has also described him as “‘an intellectual
heavyweight. He is hugely professional on every issue.’” It
also listed Bill as “a very good communicator and a trusted
adviser.” Recognized in the 2016 edition of Who’s Who Legal:
Life Sciences, they noted “He superbly handles all the
regulatory issues encountered by his clients.”

Washingtonian magazine includes Bill on its 2013 list of
Washington’s Best Lawyers as one of the region’s “best legal
minds” in the area of Healthcare Law. He was listed by
Nightingale’s Healthcare News as one of ten “Outstanding
Practice Lawyers for 2006.” He is the co-author of several
books on healthcare. Bill served on the Regulatory Relief
Committee for the American Hospital Association and served
on the Compliance Advisory Committee for the Healthcare
Financial Management Association as its Chairman. He served
as a law clerk to the Honorable Harry L. Hupp in the U.S.
District Court for the Central District of California in Los
Angeles following his graduation from Harvard Law School in
1989.